A Study of the Effect of Abemaciclib on Metformin and Iohexol in Healthy Participants

NCT02884089 | Completed Phase 1 Results

• 2 other identifiers: 16536I3Y-MC-JPCK
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study will look at how a single dose of abemaciclib will impact the body's ability to get rid of two other drugs, metformin and iohexol. In addition, this study will evaluate the effect of a single dose of abemaciclib on kidney function by measuring blood and urine markers. Side effects will also be documented. Each participant will complete four study periods. During each study period, participants will stay in the clinical research unit for nine days and eight nights. The study will last approximately 10 weeks, not including screening. Screening is required within 28 days prior to the start of the study. This study is for research purposes only and is not intended to treat any medical condition.

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of Metformin

  Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC\[0-∞\]) of Metformin was evaluated.

  Pre dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 36 hours (h) post dose

• Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Metformin

  Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Metformin was evaluated.

  Pre dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 36 hours (h) post dose

• Pharmacokinetics (PK): Renal Clearance (CLr) of Metformin

  Pharmacokinetics (PK): Renal Clearance (CLr) of Metformin was evaluated.

  Pre dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 36 hours (h) post dose

Secondary Outcomes (1)

• Pharmacokinetics (PK): Renal Clearance (CLr) of Iohexol

  Pre infusion, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6 hours post infusion

Study Arms (4)

Placebo + Metformin

PLACEBO COMPARATOR

Single dose of placebo administered orally followed by a single dose of metformin administered orally in one of four study periods.

Drug: Metformin; Drug: Placebo

Abemaciclib + Metformin

EXPERIMENTAL

Single dose of abemaciclib administered orally followed by a single dose of metformin administered orally in one of four study periods.

Drug: Abemaciclib; Drug: Metformin

Placebo + Iohexol

PLACEBO COMPARATOR

Single dose of placebo administered orally followed by a single dose of iohexol administered intravenously (IV) in one of four study periods.

Drug: Iohexol; Drug: Placebo

Abemaciclib + Iohexol

EXPERIMENTAL

Single dose of abemaciclib administered orally followed by a single dose of iohexol administered intravenously (IV) in one of four study periods.

Drug: Abemaciclib; Drug: Iohexol

Interventions

Abemaciclib DRUG

Administered orally

Also known as: LY2835219

Abemaciclib + Iohexol; Abemaciclib + Metformin

Metformin DRUG

Administered orally

Abemaciclib + Metformin; Placebo + Metformin

Iohexol DRUG

Administered intravenously (IV)

Abemaciclib + Iohexol; Placebo + Iohexol

Placebo DRUG

Administered orally

Placebo + Iohexol; Placebo + Metformin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy surgically sterile or postmenopausal females and sterile males
• Have a body mass index (BMI) between 18 and 32 kilograms per meter squared (kg/m²), inclusive at screening

You may not qualify if:

• Have known allergies to abemaciclib, metformin, iodine, iohexol, related compounds, or any components of the formulation
• Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
• Show evidence and/or positive antibodies of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

Dallas Clinical Research Unit

Dallas, Texas, 75247, United States

Location

MeSH Terms

Interventions

abemaciclib; Metformin; Iohexol

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Triiodobenzoic Acids; Iodobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5979

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: August 25, 2016
• First Posted: August 30, 2016
• Study Start: August 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: January 4, 2019
• Results First Posted: August 7, 2018

Record last verified: 2018-12

Locations

US (1)